m.unverdorben; tct 2007 1 problem the treatment of stenoses of small coronary arteries (svd) and of...
TRANSCRIPT
1M.Unverdorben; TCT 2007
Problem The treatment of stenoses of small
coronary arteries (SVD) and of restenoses after stent deployment (ISR)
still show unsatisfactory long-term results even after drug-eluting stent
deployment
Likely Solution
Using a drug-eluting balloon catheter (B.Braun Melsungen AG, Germany)
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Paccocath
Hwang, Circulation 2001; 104: 600-5
DES
Scheller, Heart 2007; 2007;93:539-
41
Paclitaxel-eluting stent (DES) vs.Paclitaxel-eluting stent (DES) vs. Paclitaxel-eluting balloon (DEB)Paclitaxel-eluting balloon (DEB)
M.Unverdorben; TCT 2007
The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease
PEPCAD I-SVD
PEPCAD II-ISR
Martin UnverdorbenClinical Research Institute, Center for Cardiovascular
Diseases Rotenburg an der Fulda, Germany
On behalf of the PEPCAD Investigators
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Primary Variable
6-month late lumen loss
Secondary Variables
Procedural success (≤30% stenosis)6-month binary restenosis rate6-month MACE
MACE at 1 and 3 years
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Outcome ComparisonDEB ITT
N=120
DEB Only
N=82
Taxus* BMS*
Follow-up [mo]
6.7±2.1 6.7±1.9 9 9
Late loss [mm]
0.3±0.55 0.18±0.38 0.490.61 0.900.63
Restenosis (segment)
15.5% 5.5% 31.2% 49.4%
Total MACE 13.7% 6.1% 18.9% 26.9%
TLR 12% 4.9% 10.4% 21.5%
Myocardial infarction
0.8% 1.2% 5.7% 2.2%
Cardiac death
0% 0% 1.9% 1.1%
*Stone, G JAMA 2005;294:1215-23
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Summary PEPCAD I
The paclitaxel-eluting balloon catheter Sequent Please (B.Braun Melsungen AG) … –was safe and associated with a high procedural success rate in de-novo lesions
–exhibited low late lumen loss after 6 months in SVD
–patients treated w/o additional stenting demonstrated a restenosis rate of 5.5%
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PEPCAD IIRandomized Comparison to
Taxusin ISR
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Primary Variable
6-month late lumen loss
Secondary Variables
Procedural success (≤30% stenosis)6-month binary restenosis rate6-month MACE
MACE at 1 and 3 years
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As-Treated Groups
Treatment w/ DEB70 Subj.
DEB only56 Subj.
DEB + BMS6 Subj.
Crossover from DES 4 Subj.
Violators 4 Subj.
Treatment w/ DES60 Subj.
DES58 Subj.
DES w/ additional DES 2 Subj.
Enrolled 131 Subj. Conventional
balloon 1 Subj. Violator from DES
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Outcome (N=126) DEB
(N=66)1
DES (N=60)1 P=
Follow-up [months] 6.2 ± 0.8 6.2 ± 0.8 0.7
Follow-up: clinical 62 (93.9%) 59 (98.3%) 0.4
Follow-up: angiographic
54 (81.8%) 53 (83.3%) 0.5
Late lumen loss [mm] 0.19 ± 0.39 0.45 ± 0.69 0.01
Binary restenosis in segment
2/54 (3.7%) 11/53 (20.8%)
0.02
Total MACE 3/62 (4.8%) 13/59 (22.0%)
0.007
TLR 2/62 (3.2%) 11/59 (18.6%)
0.008
Myocardial infarction 0/62 (0.0%) 1/59 (1.7%) 2
1
Death 1/62 (1.6%)3 1/59 (1.6%) 4
1
1 1 protocol violators excluded
2 NSTEMI side branch occlusion4 non-cardiac death3cardiac, not lesion related
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Event Free Survival (ITT/As Treated)
70
75
80
85
90
95
100
0 2 4 6 8 10
Sub
ject
s [%
]
DES/ I TT DEB/ I TT
DES/AsT DEB/AsT
p=0.07ITT p=0.007
As Treated
Months post PCI
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Summary PEPCAD II The paclitaxel-eluting balloon catheter
Sequent Please (B.Braun Melsungen AG) … –was safe and associated with a high procedural success rate in ISR
–exhibited low late lumen loss after 6 months in ISR
–was superior to the paclitaxel-eluting Taxus stent in ISR after 6 months
–has not been associated with late thrombosis in 200 patient years in SVD and ISR
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Additional Handouts
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Abbreviations and TermsAbbreviation/Term
Explanation
BMS Bare metal stent without any active coating
DEB Drug-eluting balloon catheter that delivers (antiproliferative) drugs into the vessel wall
DES Drug-eluting stent that delivers (antiproliferative) drugs into the vessel wall
Follow-up Observation period of a patient following a procedure
In-segment The 5mm of a vessel on either side of a deployed stent
ISR Renarrowing/reocclusion of a stent
Late lumen loss
Renarrowing of a stenosis after PCI [mm]
MACE Major adverse cardiac event; usually incl. heart attack, repeat angioplasty (or bypass) of the stenosis, death
PCI Percutaneous coronary intervention; treating coronary artery stenoses with catheters, incl. balloons, stents, drugs & others
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Abbreviations and Terms
Abbreviation/Term
Explanation
Restenosis Renarrowing of the target lesion after PCI of at least 50%
Stenosis Narrowing of the coronary artery [%]; considered as relevant when reaching 70% or more of the vessel diameter
Stent Mesh-like devices to scaffold arteries, which are deployed using balloon catheters. Stents may (drug-eluting) or may not (bare metal) deliver drugs to the vessel wall.
SVD Small vessel disease. Coronary artery with diamters 3.0mm
Thrombosis
Renarrowing/reocclusion of a vessel mainly by platelets
TL Target lesion; lesion that has been treated
TLR Target lesion revascularization; lesion that has become narrow again (usually ≥ 70%) and needs „rework“ by PCI or bypass
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Contact Information
Martin Unverdorben
MD, PhD, Associate Professor of Medicine
+1 804 651 3089 (EST) [email protected]